1. Field of the Invention
The present invention relates generally to medical devices and more specifically, to a splittable introducer having a hemostatic valve system for use in inserting a medical device into a body vessel.
2. Background
Numerous procedures have been developed in modern medicine requiring the percutaneous insertion of one or more medical devices into the vascular system of a patient. Such procedures include, for example, percutaneous transluminal coronary angioplasty (PTCA), X-ray angiographic procedures, and the alike.
The medical devices intended for use in such procedures may be introduced into the vascular system by a variety of known techniques. One widely-used technique is the Seldinger technique. In the Seldinger technique, a surgical opening is made in an artery or vein by a needle, and a guide wire is inserted into the artery or vein through a bore in the needle. The needle is thereafter withdrawn, leaving the guide wire in place. A dilator which is positioned within the lumen of the introducer device is then advanced over the guide wire into the artery or vein. Once the introducer is properly positioned within the artery or vein, the dilator is withdrawn. The introducer may then be used to insert therethrough a variety of medical interventional devices, such as for example, catheters, cardiac leads, and the alike.
One type of introducer is a splittable introducer (also referred to as a peelable introducer, peelable sheath or peel-away sheath). A splittable introducer is used to introduce a medical device, such as a catheter, into a patient and can be subsequently peeled off or away from the medical device to free the medical device from the introducer. One problem with a splittable introducer, however, is that once its sheath is inserted, and the dilator and guide wire have been removed, the sheath provides a passage for the flow of blood. Uncontrolled blood loss through the sheath can have a negative effect on the patient. Another problem with a splittable introducer is that its sheath allows for the introduction of air into the body vessel of the patient. If air is inadvertently introduced into the patient's vein, an air embolism may result with negative effects.
Accordingly, further improvements and enhancements are needed for a splittable introducer, which provides an efficient seal and avoids at least some of the problems encountered with current splittable introducers.